MAUDE Adverse Event Report: COOK INC ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET; DYB INTRODUCER, CATHETER

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a female patient required a rosch-uchida transjugular liver access set for a transjugular intrahepatic portosystemic shunt (tips) procedure.During the procedure, the operator found the connection between the valve at the end and sheath "loosened" when the sheath was inserted.Then, the valve detached from the sheath.The device was removed and a new device was placed to successfully finish the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: uangzhou pumei medical tech.In china informed cook that on (b)(6) 2021 the sheath in a rups-100 (rosch-uchida transjugular liver access set) from lot 13209365 had separated.The failure occurred during the procedure and the user removed the device and finished with another rups-100 set.It is reported that the patient did not experience any adverse effects due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device, as well as a visual inspection and functional test of the returned device were conducted during the investigation.Cook received one used large check-flo introduce sheath.Inspection found the check-flo is separated from the sheath and pushed down onto the sheath.The check-flo was disassembled to find the flare remained between the cap and the check-flo body.There is no indication the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.Review of the device master record concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: warnings: ¿-if flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ how supplied: ¿-upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot and component lot found no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.No non-conforming product from this lot exists in house or in the field.The user did not note any damage before attempting to use the device and the failure occurred during advancement, so damage in transportation or storage is unlikely.Based on the information provided, the examination of returned product, the results of the investigation, and as there is no evidence of manufacturing deficiencies, the cause of this event is component failure.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ROSCH-UCHIDA TRANSJUGULAR LIVER ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11336879
• MDR Text Key: 232600661
• Report Number: 1820334-2021-00344
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10827002069296
• UDI-Public: (01)10827002069296(17)230526(10)13209365
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K171820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: N/A
• Device Catalogue Number: RUPS-100
• Device Lot Number: 13209365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG